Explore the critical components of Process Validation for medical device manufacturers. This helpful resource simplifies complex requirements and guides companies through the key milestones in validation.

A Systematic Approach to Process Validation

Process Validation has become a recent buzzword for all sectors of the medical device industry. The route to ensuring that a process is fully validated is not always a clear one, which can all too often result in an inadequately validated process.

This whitepaper will guide companies through the key milestones required to successfully validate a process to meet both European and US requirements. It examines important considerations during process validation including:

The Installation Qualification (IQ) requirement to provide documented evidence that all equipment used meets installation requirements

The Operational Qualification (OQ) requirements including the sampling plan and process capability

The Performance Qualification (PQ) to demonstrate documented evidence of the occurrence under actual manufacturing conditions